MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SCREWS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	CTL4.5-022-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record for the screw confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections prior to release.A supplemental report will be submitted with device evaluation findings.
Event or Problem Description
It was reported that in the early lengthening phase, it was discovered that the patient's tibia was developing a slight procurvatum deformity; however it was decided to continue with the lengthening process.During removal of the plate after lengthening had reached an acceptable result, one of the 4.5mm locking screws in the distal segment of the plate was noted to be broken and it was also discovered that the screw had been implanted with purchase in the near cortex only.Additionally, it was reported the plate had been implanted in an inverted orientation.The surgeon made alignment adjustments and reinforced the surgical site with a static locking plate.Report 1 of 2.

• Brand Name: PRECICE SCREWS
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11589047
• Report Number: 3006179046-2021-00210
• Device Sequence Number: 11649358
• Product Code: HSB
• UDI-Device Identifier: 00887517029980
• UDI-Public: 887517029980
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K193617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CTL4.5-022-S
• Device Lot Number: ACAAAE0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR